Inspace Baloon TM.
Rotator cuff tears (RCTs) are among the most common tendon injuries seen in orthopedic patients, resulting in significant pain and disability. The incidence of rotator cuff tears increases in frequency with age and is often associated with degeneration of the tendons. Full thickness tears of the rotator cuff are among the most common sources of pain and dysfunction in the shoulder.
A range of surgical options are available including debridement, with or without partial tendon repair, tendon transfer, muscle-tendon slide procedures, the utilization of rotator cuff allografts and synthetic graft materials, and , reverse Arthroplasty.
The InSpace™ System is designed to create a physical barrier between tissues in the subacromial space. The biodegradable balloon acts as a spacer between the acromion and the humeral head, allowing smooth gliding and frictionless movement between the two bones, emulating the function of the original bursa.
Implantation is simple as the device can be deployed using minimally invasive techniques such as arthroscopy or mini-open surgery. InSpace™ deployment, from introduction of the device to sealing and retraction of the deployer, usually takes less than 10 minutes.
Clinical data has shown that approximately 75% of patients showed improvement in their Total Constant Score, increasing from implantation up to the longest available data, at 5-years follow up.
The InSpace™ device is a biodegradable, balloon-shaped spacer that is deployed arthroscopically into the subacromial space of the shoulder, acting as a spacer in patients with massive rotator cuff tears.Some massive tears and /or poor tendon and muscle quality will not allow a successful rotator cuff repair. The optimal treatment for massive rotator cuff tears is still not known. There are many treatment options, all with their own benefits and risks. The exact choice of treatment depends on the patient’s problems, age, functional requirements and the surgeons’s preferences and experience.
The InSpace™ device is composed of an introducer and a balloon shaped spacer made of a biodegradable polymer which is a widely used material in the medical industry. The spacer is positioned by an arthroscopic procedure in the subacromial space between the humerus head and the acromion. Once positioned, the spacer is inflated with physiological water to allow smooth and frictionless gliding between the shoulder bones (see the diagram below showing the position of the implanted balloon in relation to the bones and muscles).
First step is debridement Measure the Space to size Baloon
As pain associated with the ruptured tendons may cause abnormal motion and limit rehabilitation, breaking the pain cycle may ease rehabilitation, allow pain relief ,improve shoulder function and potentially eliminate or defer the need for more extensive shoulder surgery. The spacer degrades within 6-12 months.
The InSpaceTM Balloon is intended to decrease pain associated with ruptured tendons following a rotator cuff tear. It has been approved by the European authorities since July 2010.
The surgical procedure of InSpaceTM balloon insertion is similar to other routine rotator cuff surgeries, conducted in an operating theatre, under general or regional anaesthesia using an arthroscopic approach.